Clinical Project Leader Associate

As our company is growing, we are currently looking for a talented Clinical Project Leader Associate. We offer an open-ended contract in a company of human-size in full development, with a short reporting line and a committed management.

Main responsibilities:

As Clinical Project Leader Associate, you will provide routine and daily support to the Clinical Project Leader (CPL):

  • Manage and follow-up of the operations related to clinical activities to ensure the smooth running of the Aquilon clinical studies conducted by third parties (including Contract Research Organizations [CRO], bioanalytical laboratories, Contract Development and Manufacturing Organizations [CDMO], etc.) ;
  • Work closely with the CPL regarding the planning, timelines compliance and prioritization of the activities internally and with third parties;
  • Manage and provide accountability for day-to-day operations of the clinical trials, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
  • Assist in the selection and activation of clinical sites
  • Manage site’s initiation process under CPL’s supervision
  • Coordinate, schedule, and deliver training for investigator sites
  • Provide supplies to investigator sites (e.g: study materials, investigational medicinal products…) and fulfill requests for resupplies.
  • Participate in vendors selection
  • Assist the CPL for the preparation and follow-up of submission dossiers to the Competent Authorities and Ethics Committees
  • Provide oversight to all vendors, ensuring timely delivery of milestones and within budget
  • Organize meetings with all vendors, set the agenda when the meeting is initiated by Aquilon and write the minutes
  • Development and/or review of external and internal Study documents and Plans, ensuring completeness and necessary updates in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Clinical Monitoring Plans, Project Plans)
  • Set-up Study tracking and reporting tools and ensure ongoing update
  • Liaise with CDMO, CRO, central lab, and other study project stakeholders as needed
  • Monitor, File and archive the clinical documentation throughout the trial (TMF management, eTMF, etc.)
  • Provides short-term/temporary fill-in or back-up support for CPL, as needed                                             
Your professional profile:
  • Educational background: Scientific or life science BSc, MSc
  • Experience: at least 3 years professional experience in a similar domain and/or position in the pharmaceutical or biotechnology industry or in CRO. Experience in project management and interactions with third parties would be strong assets.
  • Languages: Fluency in English and French (written and oral) is required
  • Skills:
    • Excellent communication skills
    • Excellent organization skills
    • Excellent writing skills
    • Adaptability and ability to define and deal with priorities
    • Ability to work independently as well as in multidisciplinary teams
    • Good knowledge of standard MS-Office products.
  • Knowledge of applicable standards:
    • Required: GCP and ICH guidelines related to clinical trials
    • Other ICH guidelines related to the safety (S), efficacy (E) and multidisciplinary (M) aspects, etc. is a plus.
What we offer:

An open-ended contract in a company of human-size in full development, with a short reporting line and a committed management.

Remuneration in line with your experience and qualifications.

To apply, please send your resume and an application letter in English and by e-mail, with the subject “CPL associate” at: info@aquilonpharma.com.

Want to join our team?